MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X4 STR 10S 16 PLY; GAUZE SPONGE

Model Number 7317

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a gauze sponge.The customer states vistec x-ray gauze was used to pack a wound during an abdominal surgery.This item, (b)(4), is put into an operating room tray by a third party supplier avid.When the physician went to remove the gauze from the wound, pieces of gauze about 1/4 inch long had shredded and was left in the patient.The surgery being performed was a bowel resection.The physician removed shredded pieces of gauze from the patient's surgical site.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: VISTEC SPG 4X4 STR 10S 16 PLY
• Type of Device: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin rd.; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin rd.; augusta GA 30906
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3999027
• MDR Text Key: 4775373
• Report Number: 1018120-2014-00012
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 140000445362X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 08/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other